GSK’s Benlysta shows sustained disease control in study

Adding GSK’s Benlysta to standard of care in patients with lupus prolonged control of disease activity, according to newly-released findings of a 10-year continuation study.

Lupus - a chronic autoimmune disease that, if uncontrolled, can lead to severe, debilitating symptoms, long-term organ damage and premature death - affects more than 20,000 people in England and Wales, and some patients with advanced disease fail to respond to current therapy.

Benlytsa (belimumab) is the first in a class of drugs called BLyS-specific inhibitors, which work by targeting a naturally occurring protein believed to play a role in the production of antibodies which attack and destroy the body's own healthy tissues.

Data from a Phase II study, presented at the Annual European Congress of Rheumatology (EULAR) 2017, showed that the percentage of patients with active systemic lupus erythematosus (SLE) responding to treatment with the biologic increased over time, with an overall response of 65.1 percent at Year 10.

Also, patients were able to reduce their corticosteroid dose over time from baseline to Year 10. Of those receiving more than 7.5 mg/day baseline prednisone, 32.6 percent (14/43) dropped their dose to ≤7.5 mg/day by Year 10, and thereby met a key treatment goal given that corticosteroid use is linked with significant side effects.

“Unlike most treatments used for SLE, belimumab has a specific mode of action that targets the underlying disease process,” noted David Roth, medicines development leader, R&D Immuno-Inflammation at GSK.

“It has consistently proven its effectiveness, with four successful pivotal trials in SLE and data now shows that the disease control is sustained, helping to stabilise day-to-day symptoms and improve outcomes for patients in the longer-term.”

Benlysta was actually cleared by European regulators back in 2011 for autoantibody-positive SLE, but was only cleared by NICE for routine NHS use in June last year.

The firm presented data from a long-term analysis last year showing low rates of organ damage progression in patients with moderate-to-severe SLE taking the drug for five years, regardless of their level of damage at the start of the trial.